NEW DELHI: A significant advancement has been made for individuals suffering from obstructive sleep apnea (OSA), with the U.S. Food and Drug Administration (FDA) approving Zepbound (tirzepatide) as the first drug treatment for this condition in adults with obesity. The approval, announced on December 20, 2024, opens the door to new avenues for managing OSA, which is known to disrupt breathing during sleep and is linked to serious health complications.
Zepbound, primarily recognized as an anti-diabetic medication and already approved for aiding weight loss, has shown promise not only for treating diabetes but also for mitigating the effects of sleep apnea. According to Dr. Sally Seymour, director of the Division of Pulmonology, Allergy, and Critical Care at the FDA, "Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea. This is a major step forward for patients with obstructive sleep apnea."
The approval is particularly important as OSA affects around 30 million adults in the United States alone, with many cases remaining undiagnosed, which can lead to severe health risks such as high blood pressure, stroke, and depression.
Zepbound operates by activating receptors for hormones secreted by the intestine, reducing appetite and food intake, which facilitates weight loss. Studies have indicated improvement not only for obesity management but also for lessening the severity of OSA symptoms. "Many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences," noted Patrik Jonsson, president of Lilly Cardiometabolic Health, emphasizing the drug’s potential to alter lives.
The FDA’s decision was based on two large-scale clinical trials involving approximately 470 adults who were either receiving standard positive airway pressure (PAP) therapy or were not using such devices. Results published indicated remarkable improvements: Zepbound reduced apnea-hypopnea index events by 25 per hour on average when compared to placebo, highlighting significant efficacy for those struggling with both obesity and sleep apnea.
For participants undergoing treatment for OSA, the weight loss was substantial—averaging around 18% to 20% throughout the trials, translating to significant health benefits. These findings present Zepbound as not only the first drug treatment approved for OSA but also as part of a broader strategy involving diet and exercise to combat the disorder.
Health experts caution, though, as Zepbound does come with potential side effects, including nausea, diarrhea, vomiting, and abdominal discomfort. More alarming are warnings associated with severe allergic reactions and possible effects on thyroid health. Caution is recommended for patients with histories of medullary thyroid cancer and those prone to severe allergic reactions to tirzepatide. It will be necessary to monitor patients closely for any adverse effects, particularly as long-term data on its safety continues to emerge.
Pricing and accessibility also remain concerns, as out-of-pocket costs for Zepbound can exceed $1,000 monthly without insurance. To help, Eli Lilly is offering discount programs and plans to launch the injectable drug under the brand name Mounjaro by 2025 after securing necessary approvals around the world, including India.
The approach adopted by Eli Lilly appears focused on improving accessibility to this new treatment option for those who may benefit significantly from it. By addressing the broader public health issues tied to obesity and sleep apnea, Zepbound offers hope on multiple fronts, potentially leading to comprehensive care strategies.
Despite the enthusiasm surrounding Zepbound’s approval, healthcare professionals urge patients and practitioners to remain vigilant about the drug's long-term effects and the necessity of complementary lifestyle changes for optimal results. A collaborative approach combining medication with healthy habits is likely the most effective strategy moving forward.
With Zepbound now available, individuals with OSA may have new opportunities to manage their symptoms more effectively, potentially changing the lives of millions who suffer from this complex and often-overlooked condition.
